US-OH, Sr Manager Regulatory Affairs MRA 2116-MZ
Job Title: Regulatory Affairs Manager
Department: Quality Assurance and Regulatory Compliance
Reports To: Sr Dir, Quality Assurance and Regulatory Compliance
Prepared Date: September 18, 2013
FLSA Status: Exempt
General Purpose of the Job. Provide guidance to client organizations and internal customers to attain and maintain official authority to market and sell their pharmaceutical products in the United States under applicable national drug laws, regulations and guidance’s.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
1. Provide regulatory guidance to clients and all departments in the company.
2. Serve as a liaison between the client, the company and regulatory authorities.
4. Manage, write, and/or review (QA) regulatory submissions, including, but not limited to:
a. Investigational new drug applications (IND’s)’;
b. New drug applications (NDA’s);
e. Annual reports;
f. Labels and labeling
g. Safety updates
h. DDMAC submissions; and
i. product registrations.
6. Provide review of client corporate documents (including labeling, marketing and promotional material) for regulatory compliance.
7. Develop, implement and review clients’ and company’s current standard operating procedures and policies to ensure corporate compliance with federal and international regulatory requirements.
8. Review regulatory publications and information to keep apprised of regulatory developments.
Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and Experience.
· Bachelor of Science degree or equivalent with five to seven years regulatory affairs experience; or equivalent combination of education and experience.
· Demonstrated knowledge of all regulatory functions including statutes, regulations and guidance documents
· Demonstrated ability to manage multiple and diverse projects concurrently.
· Demonstrated ability to develop relationships and generate collaborations.
· Strong analytical skills; a planner and implementer; proven negotiating track record.
· Excellent written and verbal communication and presentation skills.
· Team player with high integrity and an open, interactive style with strong interpersonal skills.
· Assertive, decisive and results-oriented.
Language Skills. Ability to read, analyze, and interpret common scientific and technical journals, financial reports and legal documents. Ability to respond effectively to common inquiries or complaints from customers, regulatory agencies or members of the business community. Ability to write speeches and articles for publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.
Mathematical Skills. Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
Reasoning Ability. Ability to define problems, collect data, establish facts and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
Technology Skills. To perform this job successfully, an individual should have knowledge of internet software; spreadsheet software and word processing software.
Certificates, Licenses, Registrations. None required.
Physical Demands. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit. The employee is frequently required to talk or hear. The employee is occasionally required to stand; walk and use hands to finger, handle, or feel.
Work Environment. The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
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